Biodesix Announces New Clinical Utility Evidence for the Nodify XL2® Nodule Risk Assessment Test to Be Presented at ATS 2023 International Conference

Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announces new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2023 International Conference. The meeting will take place May 19-24, 2023, in Washington, DC.

Data from the abstract titled, Assessment of an Integrated Classifier’s Ability to Distinguish Benign from Malignant Nodules: Subgroup Analysis of the ORACLE Registry, presented by Dr. K. J. Long M.D. of the Medical University of South Carolina, SC, United States, will highlight data that show that the Negative Predictive Value for the Nodify XL2 test did not differ across multiple subgroups, including method of detection (incidental vs. screening), gender, smoking status or nodule size, suggesting that the test may be utilized effectively in a broad range of patient populations.

An additional presentation titled, Shifting the Intervention Probability Curve for Lung Cancer Diagnosis Following Biomarker Implementation: A Novel Clinical Endpoint for Biomarker Clinical Trials, presented by Dr. M. N. Kammer Ph.D. of Vanderbilt University Medical Center, TN, United States highlights that use of the Nodify XL2 test in the ORACLE registry study led to more appropriate usage of interventional procedures according to the patient’s probability of cancer, and suggests that an intervention probability analysis may prove useful for assessing clinical utility of biomarkers in future randomized trials.

Both poster presentations will occur during ATS discussion Session C99 – Advances in Biomarkers Across the Lung Cancer Continuum. The session, moderated by Dr. Anil Vachani M.D., MS from University of Pennsylvania Health System, Philadelphia, PA and Dr. Nichole Tanner, M.D., MSCR from Medical University of South Carolina, Charleston, SC, will occur at the ATS meeting on May 23^rd, 2023, from 2:15-4:15PM, Room 202B (Level 2), Walter E. Washington Convention Center.

About Biodesix

Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung^® nodule risk assessment testing strategy, consisting of the Nodify XL2^® and the Nodify CDT^® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat^® targeted ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat^® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex^® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, its possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company's ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 6, 2023 or subsequent quarterly reports on Form 10-Q during 2023, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Source: Biodesix, Inc.

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